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OpenTrials
Completed

NCT Number: NCT06546254

1% Lidocaine Paracervical Block for Endometrial Biopsy

The objective of this study is to to determine whether 1% lidocaine paracervical block reduces pain during endometrial biopsy in comparison to no intervention.

The proposed study is a double-blind randomized controlled trial (RCT).

Each participant will be randomly assigned to one of two arms:

1. intervention (paracervical block - 10 mL 1% lidocaine with epinephrine) 2. control (gently tapping the cervicovaginal junction with a capped needle)

The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.

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Key information

Conditions

Endometrial Biopsy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OPG

Toronto, Ontario, M5G 1Z5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any participant > or = age 18 years old presenting for an endometrial biopsy
  • All parities of patients are eligible
  • English speaking participants only

Exclusion criteria

  • Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzos) within past 24 hours
  • Confirmed pregnancy
  • Any diagnosed chronic pain syndromes (eg. fibromyalgia, vaginismus, interstitial cystitis)
  • Contraindication to lidocaine
  • Misoprostol administration within 24 hours
  • Previous unsuccessful office attempt at endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful biopsy attempt by a different practitioner will still be eligible)

Treatment and study plan

Lidocaine 1% Injectable Solution

Drug

10 cc 1% lidocaine paracervical injection

Capped needle

Other

Tapping the cervicovaginal junction with a capped needle

Primary outcomes

  1. Global pain score

    Time frame: Immediately after the completion of the procedure

    100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable)

Secondary outcomes

  1. Pain scores during procedure

    Time frame: During the procedure

    Pain rating on scale of 0 - 10 at the following time points: baseline, after injection/control, placement of tenaculum, endometrial biopsy completion, 1-minute post-biopsy

  2. Immediate complications of endometrial biopsy and/or intervention/control

    Time frame: Immediately after the completion of the procedure

    Provider reported

  3. Difficulty for provider to complete the biopsy

    Time frame: Immediately after the completion of the procedure

    Provider reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult)

  4. Length of time for analgesia

    Time frame: During procedure

    Stopwatch

  5. Length of time for endometrial biopsy completion

    Time frame: During procedure

    Stopwatch

  6. Number of passes with biopsy pipelle to collect sufficient tissue

    Time frame: Immediately after the completion of the procedure

    Provider reported

  7. Amount of tissue obtained: scant, minimal, adequate

    Time frame: Immediately after the completion of the procedure

    Provider reported

  8. Patient satisfaction

    Time frame: Immediately after the completion of the procedure

    Survey

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

A Double-blind Randomized Controlled Trial of 1% Lidocaine Paracervical Block for Endometrial Biopsy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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